Cleared Traditional

K883905 - ARROW PNEUMOTHORAX KIT

K883905 is an FDA 510(k) clearance for ARROW PNEUMOTHORAX KIT, manufactured by Arrow Intl., Inc.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K883905 · Arrow Intl., Inc. · General Hospital
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Jan 1989
Decision
126d
Days
Class 2
Risk

K883905 is an FDA 510(k) clearance for the ARROW PNEUMOTHORAX KIT, AK-01500. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on January 19, 1989 after a review of 126 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K883905

510(k) Number K883905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received September 15, 1988
Decision Date January 19, 1989
Days to Decision 126 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 129d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOL Device Classification - Class 2, Special Controls

Product Code JOL Catheter And Tip, Suction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - JOL Catheter And Tip, Suction

All 36
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K883905.
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CURITY THORACENTESIS TRAY
K903569 · Kendall Healthcare Products Co. Div.Of Tyco Health · Sep 1990
LAPAROSCOPIC SUCTION PROBE
K893527 · Dexide, Inc. · Jul 1989
URESIL THORA-FLO THORACENTESIS PROCEDURE KIT
K872948 · Uresil Corp. · Nov 1987
DEKNATEL THORACIC CATHETER
K873517 · Deknatel, Inc. · Nov 1987
DEKNATEL TROCAR CATHETER
K873525 · Deknatel, Inc. · Nov 1987